Trends and Considerations in Global Infectious Disease Drug Dev | Page 8

Research Pipeline
In recent decades, research and development investment
for antibacterial12 and antifungal drugs has been in decline

Figure 7. Challenges

to Successful
Development: Research Pipeline 1, 10, 11, 13

because of regulatory uncertainty and poor commercial
viability, since therapy is generally short-term and generic
drugs are available for most infections. As a result, the
number of new FDA-approved antibacterial drugs has
been falling steadily. In 1990, there were nearly 20
pharmaceutical companies with large antibiotic R&D
programs, but few remain today. According to the
Infections Disease Society of America (ISDA), only two
new antibiotics have been approved in the US since 2009.
However, in recent years, R&D investment for new
antiviral drugs, especially for hepatitis C virus and vaccines, has increased substantially. In 2012, the leading
therapeutic category by number of projects in development
was immunologicals at 650, an increase from 387 in 2007.
Among the top drug categories in development worldwide
were vaccines, ranking third at 690 compounds, and
biotechnologicals at 191 compounds.10
In 2010, US biopharmaceutical research companies were developing about 395 medicines and vaccines to treat or prevent infectious diseases,
excluding HIV. Each of these medicines was either in clinical trials or under review by the Food and Drug Administration (FDA). Among the
medicines being tested were 145 vaccines, 88 antibiotics/antibac ѕɥ